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510(k) K852541

STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS by Storz Instrument Co. — Product Code GFI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1985
Date Received
June 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Osteotome, Manual
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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